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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05281978
Other study ID # 22651
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2022
Est. completion date August 1, 2023

Study information

Verified date August 2023
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study will test the preliminary efficacy of a novel 12-week social cognitive theory-based intervention that will target reducing daily sitting time and increasing exercise participation among middle-aged working adults. This is a population highly susceptible to excessive sedentary time and low levels of exercise engagement. This two-arm randomized controlled trial (RCT) will examine the preliminary efficacy of decreasing sedentary time in addition to increasing moderate-vigorous intensity physical activity (MVPA) engagement, compared to a group which only receives MVPA promotion.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - 45-65 years of age by study start date - Hold full-time employment (= 30 hours/week) at one or more jobs - Hold a sedentary-based job (which also allows for ability to freely move about during the workday) - Low active (engage in =2 days of 30+ minutes of structured moderate-vigorous intensity exercise/week) - Physician's consent to participate in aerobic testing and/or the exercise program (if needed based on Physical Activity Readiness Questionnaire responses) - Ambulatory - Absence of health conditions that may be made worse by exercise - Ability to complete all testing assessments in-person - Access to a laptop/desktop/phone with Zoom web-conferencing software - Fluent in English Exclusion Criteria: - Under 45 or over 65 years of age - Not holding full-time employment (work < 30 hours/week at one or more jobs) - Hold a job(s) which is classified as light, medium, heavy, or very heavy work - Hold a sedentary-based job which does not allow for free movement throughout the workday (i.e., bus driver) - High active (engage in > 2 days or 30+ minutes of structured moderate-vigorous intensity exercise/week) - Non-consent of physician - Non-ambulatory (i.e., use of walkers, wheelchair, cane, etc.) - Presence of health conditions that may be made worse by exercise. - Unable to complete assessments in-person - No access to laptop/desktop/phone with Zoom software

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Decrease Sedentary Time + Increase MVPA group
12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise; personalized step count goals to increase daily volume of physical activity and displacement of sedentary time
Increase MVPA group
12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise

Locations

Country Name City State
United States Univeristy of Illinois Urbana-Champaign Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in average daily step counts Participants will wear a hip-based pedometer for 7 days at baseline and 12 weeks Baseline,12 weeks
Primary Changes in average daily sedentary time Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent sedentary. Baseline,12 weeks
Primary Changes in average daily light-intensity physical activity Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent engaged in light-intensity physical activity. Baseline,12 weeks
Primary Changes in average daily moderate-vigorous intensity physical activity Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent engaged in moderate-vigorous intensity physical activity. Baseline, 12 weeks
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